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    Summary
    EudraCT Number:2009-013837-92
    Sponsor's Protocol Code Number:113459
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-03
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-013837-92
    A.3Full title of the trial
    A phase III, open, randomized, trial to evaluate the immunogenicity and safety of a single or two-dose schedule of the A/California/7/2009 (H1N1)v-like candidate vaccine manufactured in Dresden adjuvanted with AS03A, in adults aged 18 years and above
    A.3.2Name or abbreviated title of the trial where available
    FLU D-PAN H1N1-008
    A.4.1Sponsor's protocol code number113459
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Biologicals
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGlaxoSmithKline (GSK) Biologicals' A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03
    D.3.2Product code GSK2340272A
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSplit virion, inactivated A/California/7/2009 (H1N1)v-like
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Immunization against A/California/7/2009 (H1N1)v-like influenza in male and female subjects aged 18 years and above.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that vaccination with one dose of the H1N1 candidate vaccine (A/California/7/2009 (H1N1)v-like strain) containing 3.75 µg of HA adjuvanted with AS03A results in an Haemagglutination Inhibition (HI) immune response to the vaccine-homologous virus that meets or exceeds the EMEA (CHMP) guidance targets for pandemic vaccine seroconversion rate (SCR), seroprotection rate (SPR), and geometric mean fold rise (GMFR) at 21 days after vaccination in adults within the 18 to 60 years and above 60 years age strata.
    E.2.2Secondary objectives of the trial
    To evaluate the HI immune response to the vaccine homologous virus in terms of CHMP criteria 21 days after the first dose of vaccine
    To assess whether vaccination with two doses of the H1N1 candidate vaccine results in an HI immune response to the vaccine homologous virus that meets or exceeds CHMP guidance targets for pandemic vaccine 21 days after the first dose
    To describe the persistence of the HI vaccine-homologous response against (H1N1)v-like antigen at Days 42, 182 and 364 in adults after one dose of H1N1 vaccine and at Days 182 and 364 after two doses
    To describe the immunogenicity to A/California/7/2009 (H1N1)v-like antigen at Day 0, 21, 42, 182 and 364 in terms of neutralizing antibodies in adults in a subset
    To describe the safety of the vaccine regimens in terms of solicited AEs, 7 days post-vaccination; unsolicited AEs, 21 or 84 days post-dose 1 and 63 days post-dose 2; AESIs for the entire study period, SAEs and biochemical parameters at Day 0, 21, 42, 182 and 364
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •A male or female aged 18 years or above at the time of the first vaccination.
    •Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
    •Written informed consent obtained from the subject.
    •Satisfactory baseline medical assessment by history and physical examination. Stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment.
    •Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
    •Female subjects of non-childbearing potential may be enrolled in the study.
    •Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
    •Female subjects of childbearing potential may be enrolled in the study, if the subject:
    -has practiced adequate contraception for 30 days prior to vaccination, and
    -has a negative pregnancy test on the day of vaccination, and
    -has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
    E.4Principal exclusion criteria
    •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. Potential subjects in the follow-up phase of a prior investigational study may be enrolled if the investigator’s judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
    •Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
    •Presence of an axillary temperature ≥ 37.5ºC, or acute symptoms greater than “mild” severity on the scheduled date of first vaccination.
    •Diagnosed with cancer, or treatment for cancer, within the past 3 years.
    -Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
    -Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enrol within 3 years of diagnosis, but other histological types of skin cancer require a 3 year untreated and disease-free window as above.
    -Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic hormonal therapy are excepted and may enrol.
    •Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus infection.
    • Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone when administered for > 2 weeks. Inhaled and topical steroids are allowed.
    •Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
    •Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
    •An acute evolving neurological disorder or history of Guillain-Barré syndrome.
    •Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
    •Administration of any vaccines within 30 days before vaccination.
    •Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
    •Pregnant or lactating female
    •Female planning to become pregnant or planning to discontinue contraceptive precautions.
    •Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
    E.5 End points
    E.5.1Primary end point(s)
    •Humoral immune response in terms of Haemagglutination Inhibition (HI) antibodies.
    In subjects receiving two doses of 3.75 µg of A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03A
    -SCR at 21 days after first dose of H1N1 vaccine (Day 21)
    -SPR at 21 days after first dose of H1N1 vaccine (Day 21)
    -GMFR at 21 days after first dose of H1N1 vaccine (Day 21)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    /
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state240
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 240
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    As it is a prophylactic study, subjects are healthy and there is no plan of care after the study end. Subjects may be further solicited to participate in a follow-on booster and/or extension study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-17
    P. End of Trial
    P.End of Trial StatusCompleted
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